A Multicenter, RandomiZed, Active-ControLled Study to Evaluate the Safety and Tolerability of Two Blinded Doses of Abelacimab (MAA868) Compared with Open-Label Rivaroxaban in Patients with Atrial Fibrillation (AZALEA)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509066-38-00

Acronym

ANT-006

Enrollment

896

Registered

2024-02-07

Start date

2021-04-16

Completion date

Unknown

Last updated

2025-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Brief summary

Time to first event of composite of International Society on Thrombosis and Haemostasis (ISTH)-defined major bleeding or CRNM bleeding events.

Detailed description

Time to first event ISTH-defined major bleeding events., Time to first event ISTH-defined major or minor bleeding events.

Interventions

DRUGAbelacimab 150 mg/ml solution for infusion

DRUGXarelto 20 mg film-coated tablets

DRUGXarelto 15 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Time to first event of composite of International Society on Thrombosis and Haemostasis (ISTH)-defined major bleeding or CRNM bleeding events.	—

Secondary

Measure	Time frame
Time to first event ISTH-defined major bleeding events., Time to first event ISTH-defined major or minor bleeding events.	—

Countries

Czechia, Hungary, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026